Summary

Mood journaling is a cornerstone of self-management in major depressive disorder (MDD).
Research over the last decade has shown that electronic mood journals are superior to paper
ones. One potential advantage of mental health telemetry (MHT), which use cell phones to
collect mood journal data, is that electronic journal data can easily be converted into
graphical records, allowing people living with MDD to readily spot trends, correlations, or
patterns in ways that would be quite challenging using paper diaries. This information
should make it easier to recognize and evaluate changes in mental health status -- the first
two steps in the process of self-management. The investigators will develop and deploy a
visualization module for patients with which to explore their own MHT data sets on the same
cell phones which they record their journals, and test the investigators hypotheses that
their enhanced MHT system will (i) improve patients' ability to self-manage MDD and (ii)
enhance their quality-of-life.

The study is a non-randomized, un-blinded, A-B-A' (modified single-subject withdrawal
design, with user choice of treatment or withdrawal in the A' stage) study, to explore the
utility of MHT as a tool for enhancing self-management and QoL for persons living with MDD.
The aims of this study are to explore the impact of MHT on subjects' self-management and
QoL, and to gauge participants' perceptions of MHT's utility.

Patients will be given software for Mental Health Telemetry (MHT), which allows them to record symptom intensity, hospital / ER visits, life events, etc., and to visualize their MHT data. Patients will be encouraged to make MHT entries once daily at a pre-determined time while in this arm, and will be prompted via text message by the MHT software to do so.

mht

MHT and visualizer contains mood information about the patient themselves, which allows for self management of the mood disorder. Self-management interventions promote early recognition of mood episodes, medication adherence and self-management skills which have shown to improve outcomes in depression. MHT encourages patients to take an active role by engaging in mood journaling, while making this information available in explorable form to the patient and his / her team of clinicians.

Patients exiting the MHT arm will be given the choice to continue with MHT for a further two months or whether to resume TAU (i.e., no further use of MHT) for the remaining two months.

mht

MHT and visualizer contains mood information about the patient themselves, which allows for self management of the mood disorder. Self-management interventions promote early recognition of mood episodes, medication adherence and self-management skills which have shown to improve outcomes in depression. MHT encourages patients to take an active role by engaging in mood journaling, while making this information available in explorable form to the patient and his / her team of clinicians.

Primary Outcomes

Measure

Change in self-management ratings

time frame:
two months and four months

Secondary Outcomes

Measure

Change in Quality-of-life (QoL) ratings

time frame:
two months and four months

Eligibility Criteria

Male or female participants at least 14 years old.

We will recruit (n=113) patients with a Diagnostic and Statistical Manual, 4th Ed.
(DSM-IV) diagnosis of MDD, confirmed using the MDD section of the MINI. All recruits will
own or use a web-enabled cell phone.
Exclusion Criteria:
- self-disclosed illiteracy;
- blindness;
- inability to be successfully trained in the use of MHT

Additional Information

Official title

Mental Health Telemetry for Self-Management in Major Depression

Principal investigator

David M Kreindler, MD

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.